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How Safe if Your Children's Bubble Bath?

By David Steinman, from Healthy Living

A Doctors' Prescription for Healthy Living special investigation has revealed that children's bubble bath products contain potentially harmful ingredients and contaminants. According to government studies, some of the ingredients in children's bubble bath products are cancer-causing while other ingredients are likely to be contaminated with undisclosed cancer-causing chemicals or to cause the formation of undisclosed cancer-causing chemicals in products themselves.

Labeled Toxins, Hidden Toxins

According to our in-market survey, many children's bubble bath products contain ingredients with either diethanolamine- or triethanolamine-based compounds. These are used as emulsifiers or foaming agents and generally are found at levels of one to five percent of a product's formulation, according to a December 9, 1999 Food and Drug Administration Fact Sheet. These chemicals may be abbreviated on labels as DEA and TEA and are usually shown bound to other compounds as in cocamide DEA or TEA-PEG 3 cocamide sulfate. These ingredients pose two hazards. They may cause the formation of cancer-causing nitrosamines in products, while some DEA compounds have shown disturbing evidence that they may be directly cancer-causing.

Read the The Safe Shopper's Bubble Bath Investigation

Nitrosamines

The problem with both DEA and TEA is their propensity to form a chemical reaction with sodium nitrite (which is used as a preservative in raw materials or present as an environmental contaminant and not disclosed on cosmetic labels). In this reaction, these chemicals' amines combine with nitroso compounds to form a nitrosamine. The specific nitrosamine formed is known as N-nitrosodiethanolamine or NDELA. Most nitrosamines, including those formed from DEA or TEA, are carcinogenic.

But what makes them of special concern is that these chemicals need not be swallowed to do damage. According to experimental studies done in the 1970s by Dr. H. Maibach up to 35 percent of TEA applied topically can enter the bloodstream. Other studies have found that products such as sun tan lotions that are left on the skin for extended duration of time produce the greatest absorption.

In Congressional testimony during this period, Dr. David H. Fine, the chemist who uncovered NDELA contamination in cosmetics, reported that a person using a nitrosamine-contaminated cosmetic would be applying 50 to 100 micrograms of nitrosamine to the skin each time the product is used. By comparison, a person consuming sodium nitrite-preserved bacon is exposed to less than one microgram of nitrosamine.

Furthermore, in the 1970s the FDA published a notice in the Federal Register in which it urged the industry to remove these products from cosmetics. The agency stated that cosmetics containing nitrosamines may be considered adulterated and subject to enforcement action. The industry made some progress by using higher quality control standards in its selection of raw materials.

However, some activists believe nitrosamine contamination has not been adequately addressed by the cosmetic industry. In surveys of cosmetic products conducted in 1991-92, NDELA was found in 65 percent of the samples at levels up to three parts per million, according to FDA records. Not all products containing DEA or TEA contain nitrosamines. Some may; others will not. Yet because of the failure of the FDA to request Congress to enact adequate product label disclosure legislation, the consumer has no way of knowing which products are contaminated with nitrosamines. That leaves the consumer to play carcinogen roulette and hurts the entire cosmetic industry, making all products suspect.

The FDA accepts that the presence of DEA and TEA in cosmetics can pose a significant consumer health threat. And studies would seem to indirectly suggest that there might indeed be a risk to our children. Although no studies to date have been done on cosmetics and nitrosamine-related cancer risk, studies have found a correlation between nitrosamine-contaminated foods and childrens' leukemia and brain cancer. Thus, it would seem we should reduce our children's exposure to nitrosamines whenever possible. More recently, these same chemicals were shown to possibly present another, much more direct risk. According to a 1998 report from the federal National Toxicology Program, two dermally applied DEA-based compounds‹cocamide DEA and lauramide DEA‹have been demonstrated to be cancer-causing in at least in one species of animal. For the DEA-related ingredients, the NTP study suggests that the carcinogenic response is linked to possible residual levels of DEA which in itself was found to be cancer-causing. These findings are preliminary and will need to be further confirmed. They are not enough at this time to classify either chemical as a full-fledged probable human carcinogen, but findings like these must be taken seriously.

The FDA has certainly taken notice. On December 9, 1999 the FDA Center for Food Safety and Applied Nutrition Office of Cosmetics issued a Fact Sheet that noted, "FDA takes the results of the NTP study very seriously and has made the assessment of public health risk one of the highest priorities for the cosmetics program." In our market survey of products, we found several products containing cocamide DEA and many that contained lauramide DEA. It should also be noted even the most pure TEA used in cosmetic products contains a small amount of residual free DEA.

The industry defends its use of lauramide DEA and other DEA- and TEA-based compounds by saying that bubble bath presents only a short-term exposure, as it is considered a rinse-off product. One company spokesperson said that lauramide DEA should not be removed from products as it is not widely recognized as a carcinogen.

1,4-dioxane

There is another family of chemical ingredients used in children's bubble bath. Ethoxylated alcohols are used as surfactants, detergents, foaming agents, emulsifiers, wetting agents, and solvents. Both our own commissioned independent laboratory testing and that of the federal government have documented ethoxylated alcohol compounds are frequently contaminated with 1,4-dioxane, which is carcinogenic and is listed by the federal government as a probable human carcinogen. The evidence that incriminates 1,4-dioxane as a carcinogen is substantial. According to NTP studies, the chemical has induced cancer in both sexes of rats and both sexes of mice. As Dr. William Lijinsky, former director of the Chemical Carcinogenesis Program at the Frederick Cancer Research Center, stated on June 6, 1989 in testimony before the U.S. Senate Committee on Labor and Human Resources, "Well-conducted 2-year bioassays of substances in 2 species of rodents at high but nontoxic doses that give rise to a statistically significant number of tumors compared with controls in at least one sex of one species identify them as carcinogens."

Meanwhile, according to the Consumer Product Safety Commission, the presence of 1,4-dioxane, "even as a trace contaminant is cause for concern." Studies show that dioxane readily penetrates human skin, according to the FDA Cosmetic Handbook Our own testing at The Doctors' Prescription for Healthy Living has confirmed 1,4-dioxane contamination is common in bubble bath products and other cosmetics. In our testing, about half of the cosmetic products were contaminated with 1,4-dioxane.

The best way to protect yourself or your children is to recognize ingredients containing ethoxylated alcohols (and most likely to be contaminated with 1,4-dioxane). These include ingredients with the prefix, word, or syllable PEG, Polyethylene, Polyethylene Glycol, Polyoxyethylene, eth (as in sodium laureth sulfate), or oxynol. Both polysorbate 60 and polysorbate 80 may also be contaminated with 1,4-dioxane.

Are these chemicals real hazards or are we being alarmist? Ultimately, that is a decision for each and every parent to make. Our endeavor in providing this information is to provide concerned consumers with the opportunity to take a precautionary approach.

The cosmetic industry calls such exposures‹even if they are cumulative‹trivial. But Dr. Lijinsky notes, "In view of the small amount of information about the mechanisms by which chemicals give rise to cancer (and the uncertainty about the relevance of that information), it is unwise to permit officials or experts to calculate tolerable or Śsafe' exposure for humans to carcinogens."

Although other experts may disagree with Dr. Lijinsky, we tend to agree.

Read the The Safe Shopper's Bubble Bath Investigation

References

"Bioassay of 1,4-Dioxane for possible carcinogenicity (CAS No. 123-91-1)." National Toxicology Program, TR-80.

Bronaugh, R.L., et al. "The effect of cosmetic vehicles on the penetration of N-nitrosodiethanolamine through excised human skin." J Invest Dermatol; 1981; 76(2): 94-96.

Cosmetic Handbook. U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Division of Colors and Cosmetics.FDA/IAS Booklet 1992.

Federal Register, April 10, 1979 (44 FR 21365).

Food and Drug Administration. "Progress report on the analysis of cosmetic products and raw materials for nitrosamines," March 1, 1988.

Maibach, H. "NDELA—Percutaneous Penetration." FDA Contract 223-75-2340, May 19, 1978.

Nitrosamine-contaminated cosmetics; call for industry action; request for data." Federal Register, April 10, 1979; 44(70): 21365.

Peters, J.M., et al. "Processed meats and risk of childhood leukemia (California, USA)." Cancer Causes and Control, 1994; 5: 195-202.

Sarasia. S. & Savitz, D.A. "Cured and broiled meat consumption in relation to childhood cancer: Denver, Colorado (United States)." Cancer Causes and Control, 1994; 5: 141-148.

Sixth Annual Report on Carcinogens, 1991. Summary. U.S. Department of Health and Human Services, Public Health Service. National Institute of Environmental Health Sciences, Research Triangle Park, NC, 1991, pp. 192-195.

Testimony of Dr. David H. Fine before the Subcommittee on Oversight and Investigations of the Committee on Interstate and Foreign Commerce, House of Representatives, Second Session, February 2, 1978.

"Toxicology and carcinogenesis studies of coconut oil acid diethanolamine condensate (CAS NO. 68603-42-9) in F344/N rats and B6C3F1 mice (dermal studies)." National Toxicology Program, TR-479, 1988.

"Toxicology and carcinogenesis studies of diethanolamine (CAS No. 111-42-2) in F344/N rats and B6C3F1 mice (dermal studies)." National Toxicology Program, TR-478, 1998.

"Toxicology and carcinogenesis studies of lauric acid diethanolamine condensate (CAS NO. 120-40-1) in F344/N rats and B6C3F1 mice (dermal studies)." National Toxicology Program, TR-480, 1998.

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